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Krill Oil Study Compared to Fish Oil

This study has been completed.
Sponsor:
Collaborator:
Enzymotec
Information provided by (Responsible Party):
Dr. Peter Jones, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01323036
First received: March 23, 2011
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
  Purpose

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo.


Condition Intervention
Healthy Volunteers
 Dietary Supplement: Krill oil
Dietary Supplement: Fish Oil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Bioavailability of Krill Oil Compared to Fish Oil in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Fish oil
U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Bioavailability [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Krill Oil
N/A
 Dietary Supplement: Krill oil
Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
Experimental: Fish Oil
N/A
 Dietary Supplement: Fish Oil
Fish oil: Total omega-3 fatty acids: 560-660 mg

Detailed Description:

The main purpose of the study is to evaluate the absorption of omega-3 fatty acids into the blood following consumption of krill oil compared with fish oil and placebo. An additional purpose is to evaluate the lipid-lowering efficacy and safety of consumption of Krill Oil and Fish Oil to a placebo product. It has been shown that the ingestion of Krill Oil leads to better absorption of omega-3 fatty acids compared to ingestion of Fish Oil. It was also shown that consumption of krill oil and fish oil result in a favorable modification of lipid profiles. Therefore, it is anticipated that consumption of these krill oil and fish oil will improve lipid profile, as well as other health-related markers and will be safe and well tolerated.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy men and premenopausal not pregnant or nursing women between 18 and 49 years old.

Exclusion Criteria:

  • smokers
  • rheumatoid arthritis
  • chronic illness
  • cardiovascular problems
  • dyslipidemia
  • liver and kidney disease
  • diabetes
  • endocrine or metabolic disease
  • inflammatory bowel disease
  • pancreatitis
  • gallbladder or biliary disease
  • neurological/psychological disease
  • bleeding disorders
  • experienced platelet abnormalities
  • gastrointestinal disorders that could interfere with fat absorption
  • hypertension
  • history of cancer
  • an intention to lose weight
  • use of anticoagulant
  • serum triglycerides (TG) >200 mg/dL, and/or total cholesterol (TC) >240 mg/dL, and/or LDL-cholesterol (LDL-C) >160 mg/dL
  • hypertension or lipid lowering medications
  • consumption of more than one alcoholic drinks/day
  • Consumption of more than one fish or seafood serving
  • one month prior to the start of the study
  • omega-6 fatty acids in the past 6 months
  • planned to consume seafood products or fish or to use any omega-3 or omega-6 fatty acids nutritional supplements at anytime in the duration of the study
  • planned to to become pregnant during the study period
  • BMI>28
  • allergies to fish seafood or corn
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323036

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 2N2
Sponsors and Collaborators
University of Manitoba
Enzymotec
  More Information

No publications provided

Responsible Party: Dr. Peter Jones, Director of RCFFN, University of Manitoba
ClinicalTrials.gov Identifier: NCT01323036     History of Changes
Other Study ID Numbers: B2011:014
Study First Received: March 23, 2011
Last Updated: November 21, 2012
Health Authority: Israel: Helsinki Committee

ClinicalTrials.gov processed this record on May 19, 2013